Diane Levitan
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View article: P-2334. Clesrovimab Binding Site Conservation on the RSV F Protein: An Evaluation of RSV Molecular Sequencing Data from 2019-2023 and GenBank Sequence Analysis
P-2334. Clesrovimab Binding Site Conservation on the RSV F Protein: An Evaluation of RSV Molecular Sequencing Data from 2019-2023 and GenBank Sequence Analysis Open
Background Clesrovimab is a half-life extended RSV-neutralizing antibody targeting site IV of the RSV fusion protein, that is currently in phase 3 development for the prevention of RSV in infants. As viral sequences drift over time, the po…
View article: 544 Companion diagnostic assays for pembrolizumab in patients with MSI-H/dMMR tumors
544 Companion diagnostic assays for pembrolizumab in patients with MSI-H/dMMR tumors Open
Background Pembrolizumab is approved in the United States for unresectable or metastatic microsatellite instability-high (MSI-H)/mismatch repair–deficient (dMMR) solid tumors that progress after treatment. As part of a post-marketing commi…
View article: An Exploratory Study Using Electronic Medical Records to Assess the Feasibility of Establishing Cohorts of Patients with Genetic Causes of Parkinson’s Disease
An Exploratory Study Using Electronic Medical Records to Assess the Feasibility of Establishing Cohorts of Patients with Genetic Causes of Parkinson’s Disease Open
Background: More efficient screening methods are needed to improve the ability to identify and follow genetic cohorts in Parkinson’s disease (PD). Objective: To explore the use of the electronic medical records (EMRs) to identify participa…
View article: 511. Treatment with Molnupiravir in the MOVe-In and MOVe-Out Clinical Trials Results in an Increase in Transition Mutations Across the SARS-CoV-2 Genome
511. Treatment with Molnupiravir in the MOVe-In and MOVe-Out Clinical Trials Results in an Increase in Transition Mutations Across the SARS-CoV-2 Genome Open
Background Molnupiravir (MOV), (MK-4482, EIDD-2801) is being clinically developed for the treatment of COVID-19 disease caused by SARS-CoV-2. MOV is the orally administered 5′-isobutyrate prodrug of the active, antiviral ribonucleoside ana…
View article: 80 Evaluation of the trusight oncology 500 assay for routine clinical testing of tumor mutational burden (TMB) and clinical utility for predicting response to pembrolizumab
80 Evaluation of the trusight oncology 500 assay for routine clinical testing of tumor mutational burden (TMB) and clinical utility for predicting response to pembrolizumab Open
Background Various biomarkers have been investigated for their ability to identify patients more likely to respond to immunotherapy. Recently, the PD-1 inhibitor pembrolizumab was approved by the FDA for treating patients with unresectable…
View article: Letermovir Resistance Analysis in a Clinical Trial of Cytomegalovirus Prophylaxis for Hematopoietic Stem Cell Transplant Recipients
Letermovir Resistance Analysis in a Clinical Trial of Cytomegalovirus Prophylaxis for Hematopoietic Stem Cell Transplant Recipients Open
Background Letermovir (LET), a cytomegalovirus (CMV) deoxyribonucleic acid (DNA) terminase inhibitor, was recently approved for prophylaxis of CMV infection in adult CMV-seropositive recipients of allogeneic hematopoietic stem cell transpl…
View article: Safety and Efficacy of Pembrolizumab Monotherapy in Patients With Previously Treated Advanced Gastric and Gastroesophageal Junction Cancer
Safety and Efficacy of Pembrolizumab Monotherapy in Patients With Previously Treated Advanced Gastric and Gastroesophageal Junction Cancer Open
IMPORTANCE Therapeutic options are needed for patients with advanced gastric cancer whose disease has progressed after 2 or more lines of therapy. OBJECTIVE To evaluate the safety and efficacy of pembrolizumab in a cohort of patients with …
View article: Letermovir Resistance Genotyping in a Clinical Trial of Cytomegalovirus Prophylaxis for Hematopoietic Cell Transplant Recipients
Letermovir Resistance Genotyping in a Clinical Trial of Cytomegalovirus Prophylaxis for Hematopoietic Cell Transplant Recipients Open
Background: Letermovir (LET), an inhibitor of cytomegalovirus (CMV) DNA terminase, significantly reduced clinically-significant CMV infection (CS-CMVi) and was well-tolerated in a randomized, double-blind, placebo-controlled trial for prev…
View article: Inhibition of O-GlcNAcase leads to elevation of O-GlcNAc tau and reduction of tauopathy and cerebrospinal fluid tau in rTg4510 mice
Inhibition of O-GlcNAcase leads to elevation of O-GlcNAc tau and reduction of tauopathy and cerebrospinal fluid tau in rTg4510 mice Open
The present study demonstrates that chronic inhibition of OGA reduces pathological tau in the brain and total tau in the CSF of rTg4510 mice, most likely by directly increasing O-GlcNAcylation of tau and thereby maintaining tau in the solu…
View article: Phenotyping of adipose, liver, and skeletal muscle insulin resistance and response to pioglitazone in spontaneously obese rhesus monkeys
Phenotyping of adipose, liver, and skeletal muscle insulin resistance and response to pioglitazone in spontaneously obese rhesus monkeys Open
Insulin resistance and diabetes can develop spontaneously with obesity and aging in rhesus monkeys, highly similar to the natural history of obesity, insulin resistance, and progression to type 2 diabetes in humans. The current studies in …
View article: Pre-Analytical Considerations for Successful Next-Generation Sequencing (NGS): Challenges and Opportunities for Formalin-Fixed and Paraffin-Embedded Tumor Tissue (FFPE) Samples
Pre-Analytical Considerations for Successful Next-Generation Sequencing (NGS): Challenges and Opportunities for Formalin-Fixed and Paraffin-Embedded Tumor Tissue (FFPE) Samples Open
In cancer drug discovery, it is important to investigate the genetic determinants of response or resistance to cancer therapy as well as factors that contribute to adverse events in the course of clinical trials. Despite the emergence of n…
View article: Development and Validation of a Template-Independent Next-Generation Sequencing Assay for Detecting Low-Level Resistance-Associated Variants of Hepatitis C Virus
Development and Validation of a Template-Independent Next-Generation Sequencing Assay for Detecting Low-Level Resistance-Associated Variants of Hepatitis C Virus Open
To develop hepatitis C virus (HCV) direct-acting antiviral (DAA) drugs that can treat most HCV genotypes and offer higher barriers for treatment-resistant mutations, it is important to study resistance-associated variants (RAVs). Current c…
View article: Data Interoperability of Whole Exome Sequencing (WES) Based Mutational Burden Estimates from Different Laboratories
Data Interoperability of Whole Exome Sequencing (WES) Based Mutational Burden Estimates from Different Laboratories Open
Immune checkpoint inhibitors, which unleash a patient’s own T cells to kill tumors, are revolutionizing cancer treatment. Several independent studies suggest that higher non-synonymous mutational burden assessed by whole exome sequencing (…
View article: Mutation Detection in an Antibody-Producing Chinese Hamster Ovary Cell Line by Targeted RNA Sequencing
Mutation Detection in an Antibody-Producing Chinese Hamster Ovary Cell Line by Targeted RNA Sequencing Open
Chinese hamster ovary (CHO) cells have been used widely in the pharmaceutical industry for production of biological therapeutics including monoclonal antibodies (mAb). The integrity of the gene of interest and the accuracy of the relay of …